The Drugs Controller General of India (DCGI) has given the go-ahead for Orchid Pharma's groundbreaking Cefepime and Enmetazobactam-Antibiotic Drug Combination (NCE). The public can now purchase this innovative injectable drug, providing patients across India with significant new treatment options, thanks to this important approval.

The DCGI has approved the production and sale of Enmetazobactam, a new active pharmaceutical ingredient (API). The DCGI has also granted permission to manufacture and market Cefepime and Enmetazobactam's Finished Dosage Form (FDF) as an injected dry powder. We make this mix to treat complicated urinary tract infections (cUTI), such as acute pyelonephritis and hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), and the bacteremia associated with these conditions. By releasing this formula, Orchid Pharma aims to transform the treatment of serious infections in India, providing patients with innovative and superior treatment options.

Antimicrobial resistance (AMR) is a big problem around the world, and the approval of this antibiotic combination could not come at a worse time. The UN and WHO dubbed AMR a "silent pandemic," claiming nearly 5 million lives in 2019. AMR hurts people, but it also has big effects on the economy. According to the World Bank, AMR could add US$1 trillion to healthcare costs by 2050, meaning that the GDP would lose between US$1 trillion and US$3.4 trillion each year by 2030. The new medicine combination, which fills a big gap in the fight against antimicrobial resistance, is a powerful tool against a wide range of of serious diseases caused by bacteria that are resistant to antibiotics.

Sharing the news the managing director of Orchid Pharma, Manish Dhanuka said, "The approval of Enmetazobactam in India is personally significant to us as an Indian firm."

"We are dedicated to giving more patients across the country access to advanced treatments that are also affordable. Orchid Pharma is still committed to new ideas and is ready to help people with serious illnesses find effective solutions, especially since drug resistance is growing. Our current research and development work is aimed at meeting medical needs that aren't being met," he added.

With the approval in hand, Orchid Pharma is looking forward to a smooth launch and delivery of Enmetazobactam and its combination with Cefepime. This is a big step towards making treatment options better for severe infections in India.